Ongoing Clinical Trials in Intracerebral Hemorrhage
Ongoing Clinical Trials in Intracerebral Hemorrhage
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DOI：
10.1161/strokeaha.111.000563
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发表时间：
2013-06-01
期刊：
影响因子：
8.3
通讯作者：
Gonzales, Nicole R.
中科院分区：
文献类型：
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作者：
Gonzales, Nicole R.
冈萨雷斯et al Ongoing Clinical Trials in ICH S71 patients with ICH在一项临床试验中靶向扩展可能会稀释重组因子VIIa的治疗效果。此外，可能没有HE的患者，因此预计不会从止血治疗中获益，也存在治疗血栓栓塞并发症的风险，进一步降低了任何可测量的治疗获益。评价止血剂的临床试验的挑战包括众所周知的治疗时间限制和最有可能患有HE的患者的识别。此时，最有希望的方法来确定最有可能患有HE的患者亚组是使用放射学标记物，即斑点征。斑点征是指计算机断层扫描血管造影术上看到的血肿内的造影剂溢出区域。17使用CT血管造影斑点征（PREDICT）研究，最近已前瞻性验证斑点征作为预测ICH患者血肿生长和结局的HE预测因子。18目前有2项正在进行的临床试验使用斑点征来识别HE风险最高的患者，因此最有可能从止血治疗中获益：预测和治疗ICH生长的斑点征（STOP-IT）研究19和指导止血治疗的ICH“斑点征”选择（SPOTLIGHT）研究。20目标：二次伤害
Gonzales et al Ongoing Clinical Trials in ICH S71 patients with ICH in a clinical trial targeting expansion may dilute the treatment effect of recombinant factor VIIa. In addition, patients who may not have HE and, thus, would not be expected to benefit from hemostatic therapy are also at risk of thromboembolic complication of treatment, further reducing any measurable benefit of treatment. The challenges of clinical trials evaluating hemostatic agents include the well-known time limitation for treatment and identification of patients who are most likely to have HE. At this time, the most promising way to identify the subgroup of patients most likely to have HE is with a radiographic marker, the spot sign. The spot sign refers to an area of contrast extravasation within the hematoma seen on computed tomography angiography. 17 The spot sign has recently been prospectively validated as a predictor of HE in the Prediction of hematoma growth and outcome in patients with ICH using the CT-angiography spot sign (PREDICT) study. 18 There are currently 2 ongoing clinical trials using the spot sign to identify patients at highest risk of HE and, thus, most likely to benefit from hemostatic therapy: The Spot Sign for Predicting and Treating ICH Growth (STOP-IT) study19 and the “Spot Sign” Selection of ICH to Guide Hemostatic Therapy (SPOTLIGHT) study. 20Target: Secondary Injury